A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Launched by ASTRAZENECA · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new inhaler treatment called Budesonide/Glycopyrronium/Formoterol Fumarate (BGF MDI) to see how it affects heart and lung function in people with Chronic Obstructive Pulmonary Disease (COPD) who also have a condition called hyperinflation, where the lungs hold too much air. The study compares this inhaler to a placebo (a treatment with no active medicine) to understand if BGF MDI can help improve breathing and heart health in these patients.

People who might be eligible to join are adults who are current or former smokers with a history of smoking for at least 10 years, have been diagnosed with COPD, and have certain lung function measurements that show moderate lung problems. They should already be using some form of inhaler treatment for COPD and have no recent serious lung infections or heart problems. Women who can become pregnant must use effective birth control and test negative for pregnancy before joining. Participants can expect to use the inhaler as part of the study and have their lung and heart function regularly checked to see how well the treatment works and if it is safe. This study is still not open for recruiting participants.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
• • A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 0.7.
• • At Visit 1: A pre-bronchodilator FEV1 \< 80%.
• • At Visit 1: Peripheral blood eosinophil count \< 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count \> 300 cells/mm³ in the past 12 months.
• • At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
• • At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of \> 135% of predicted normal FRC.
• • At Visit 2: A post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted normal value.
• • Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
• • Female participants must either be not of childbearing potential or using a form of highly effective birth control.
• • All women of child bearing potential must have a negative pregnancy test at the Visit 1.
• Exclusion Criteria:
• • A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
• • History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
• • History of myocardial infarction or acute coronary syndrome.
• • History or current atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
• • Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
• • Participants with ECG QTcF interval at Visit 1 \> 460 milliseconds (ms) for males and \> 480 ms for females.
• • Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
• • Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.